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Post-covid-19 conditions in adults: systematic review and meta-analysis of health outcomes in controlled studies. 成人 19 岁后的情况:对照研究中健康结果的系统回顾和荟萃分析。
BMJ medicine Pub Date : 2024-01-29 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000723
Juan Victor Ariel Franco, Luis Ignacio Garegnani, Maria-Inti Metzendorf, Katharina Heldt, Rebekka Mumm, Christa Scheidt-Nave
{"title":"Post-covid-19 conditions in adults: systematic review and meta-analysis of health outcomes in controlled studies.","authors":"Juan Victor Ariel Franco, Luis Ignacio Garegnani, Maria-Inti Metzendorf, Katharina Heldt, Rebekka Mumm, Christa Scheidt-Nave","doi":"10.1136/bmjmed-2023-000723","DOIUrl":"10.1136/bmjmed-2023-000723","url":null,"abstract":"<p><strong>Objective: </strong>To assess the impact of post-covid-19 conditions among adults.</p><p><strong>Design: </strong>Systematic review and meta-analysis of health outcomes in controlled studies.</p><p><strong>Data sources: </strong>Two sources were searched from database inception to 20 October 2022: Cochrane covid-19 study register (comprising Cochrane Central Register of Controlled Trials, Medline, Embase, clinicalTrials.gov, World Health Organization's International Clinical Trials Registry Platform, medRxiv) and WHO's covid-19 research database.</p><p><strong>Eligibility criteria: </strong>Cohort studies recruiting more than 100 participants with a control group and a follow-up of at least 12 weeks were included. Adults who were documented to have SARS-CoV-2 infection based on clinical, imaging, or laboratory criteria were included.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data. The main outcomes included quality of life, functionality in daily activities, use of resources, recovery rates (cluster of symptoms), and the incidence of new medical diagnoses. Data were pooled using a random effects model. The risk of bias was assessed with the Joanna Briggs Institute critical appraisal tool for cohort studies.</p><p><strong>Results: </strong>We included 63 controlled cohort studies, encompassing more than 96 million participants. Based on five studies, we found a reduction in overall quality of life between individuals with confirmed SARS-CoV-2 infection versus controls at six to 24 months follow-up, although heterogeneity was very high (mean difference in EQ-5D scale -5.28 (95% confidence interval -7.88 to 2.68; I<sup>2</sup>=93.81%). Evidence from ten studies, which could not be pooled in a meta-analysis, indicated that an increased rate of functional impairment associated with SARS-CoV-2 infection. Use of care increased compared with controls at six to 24 months follow-up at intensive care units (risk ratio 2.00 (95% confidence interval 0.69 to 5.80), five studies, I<sup>2</sup>=91.96%) and in outpatient care (1.12 (1.01 to 1.24), seven studies, I<sup>2</sup>=99.51%). Regarding persistent symptoms, individuals with documented SARS-CoV-2 infection had an increased risk of having two or more persistent symptoms at follow-up, especially those related to neurological clusters (ie, risk ratio 1.51 (95% confidence interval 1.17 to 1.93), I<sup>2</sup>=98.91%). Evidence also showed an increased incidence of a wide variety of metabolic, cardiovascular, neurological, respiratory, haematological and other incident diagnoses.</p><p><strong>Conclusion: </strong>Evidence suggests functional impairment after SARS-CoV-2 infection, in addition to a higher use of resources and a higher incidence of widely varying medical diagnoses. These results should be interpreted with caution, considering the high heterogeneity across studies and study limitations related to outcome measurement and attrition of partic","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000723"},"PeriodicalIF":0.0,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139643529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Covid-19 pandemic and equity of global human papillomavirus vaccination: descriptive study of World Health Organization-Unicef vaccination coverage estimates. Covid-19 大流行与全球人类乳头瘤病毒疫苗接种的公平性:对世界卫生组织-联合国儿童基金会疫苗接种覆盖率估计值的描述性研究。
BMJ medicine Pub Date : 2024-01-29 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000726
Rebecca Mary Casey, Hiroki Akaba, Terri B Hyde, Paul Bloem
{"title":"Covid-19 pandemic and equity of global human papillomavirus vaccination: descriptive study of World Health Organization-Unicef vaccination coverage estimates.","authors":"Rebecca Mary Casey, Hiroki Akaba, Terri B Hyde, Paul Bloem","doi":"10.1136/bmjmed-2023-000726","DOIUrl":"10.1136/bmjmed-2023-000726","url":null,"abstract":"<p><strong>Objective: </strong>To analyse progress in global vaccination against human papillomavirus (HPV) during the covid-19 pandemic, with a particular focus on equity.</p><p><strong>Design: </strong>Descriptive study of World Health Organization-Unicef vaccination coverage estimates.</p><p><strong>Setting: </strong>WHO-Unicef estimates of global, regional, and national HPV vaccination coverage, before (2010-19) and during (2020-21) the covid-19 pandemic.</p><p><strong>Participants: </strong>Girls aged 9-14 years who received a HPV vaccine globally before (12.3 million in 2019) and during (2020-21) the covid-19 pandemic (10.6 million in 2021).</p><p><strong>Main outcome measures: </strong>Mean programme and population adjusted coverage for first dose HPV vaccine (HPV1) by country, country income (World Bank income categories), sex, and WHO region, before (2010-19) and during (2020-21) the covid-19 pandemic, based on WHO-Unicef estimates of HPV vaccination coverage. Annual number of national HPV vaccine programme introduced since the first HPV vaccine licence was granted in 2006, based on data reported to WHO-Unicef. Number of girls vaccinated before (2019) versus during (2020-21) the covid-19 pandemic period.</p><p><strong>Results: </strong>Mean coverage of HPV vaccination programmes among girls decreased from 65% in 2010-19 to 50% in 2020-21 in low and middle income countries compared with an increase in high income countries from 61% to 69% for the same periods. Population adjusted HPV1 coverage was higher among girls in high income countries before and during the covid-19 pandemic than in girls in low and middle income countries. During the covid-19 pandemic, population adjusted HPV1 coverage among boys in high income countries was higher and remained higher than coverage among girls in low and middle income countries. Globally, 23 countries recorded a severe reduction in their HPV programme (≥50% reduction in coverage), and another 3.8 million girls globally did not receive a HPV vaccine in countries with existing HPV vaccination programmes in 2020-21 compared with 2019. A reduction was seen in the annual rate of new introductions of national HPV vaccine programmes during 2020-21, affecting countries in all income categories, followed by an increase in introductions during 2022. During the second half of 2023, several low and middle income countries with large birth cohorts and a high relative burden of cervical cancer have yet to introduce HPV vaccination.</p><p><strong>Conclusions: </strong>Although HPV vaccines have been available for more than 15 years, global HPV vaccination coverage is low. During the covid-19 pandemic period (2020-21 globally), worsening coverage, delayed introductions of national vaccine programmes, and an increase in missed girls globally (ie, girls who did not receive a HPV vaccine compared with the previous year in countries with an existing HPV vaccination programme) that disproportionately affected girls in l","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000726"},"PeriodicalIF":0.0,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10826539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139643511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study. 欧盟临床试验登记册上登记的临床试验结果的可用性:横断面审计研究。
BMJ medicine Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI: 10.1136/bmjmed-2023-000738
Nicholas J DeVito, Jessica Morley, James Andrew Smith, Henry Drysdale, Ben Goldacre, Carl Heneghan
{"title":"Availability of results of clinical trials registered on EU Clinical Trials Register: cross sectional audit study.","authors":"Nicholas J DeVito, Jessica Morley, James Andrew Smith, Henry Drysdale, Ben Goldacre, Carl Heneghan","doi":"10.1136/bmjmed-2023-000738","DOIUrl":"10.1136/bmjmed-2023-000738","url":null,"abstract":"<p><strong>Objective: </strong>To identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.</p><p><strong>Design: </strong>Cross sectional audit study.</p><p><strong>Setting: </strong>EUCTR protocols and results sections, data extracted 1-3 December 2020.</p><p><strong>Population: </strong>Random sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).</p><p><strong>Main outcome measures: </strong>Proportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.</p><p><strong>Results: </strong>In the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1).</p><p><strong>Conclusions: </strong>EUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"3 1","pages":"e000738"},"PeriodicalIF":0.0,"publicationDate":"2024-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10806997/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139565387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transgender identity in young people and adults recorded in UK primary care electronic patient records: retrospective, dynamic, cohort study. 英国初级保健电子病历中记录的年轻人和成年人的跨性别认同:回顾性、动态、队列研究
BMJ medicine Pub Date : 2023-11-28 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000499
Douglas Gordon John McKechnie, Elizabeth O'Nions, Julia Bailey, Lorna Hobbs, Frank Gillespie, Irene Petersen
{"title":"Transgender identity in young people and adults recorded in UK primary care electronic patient records: retrospective, dynamic, cohort study.","authors":"Douglas Gordon John McKechnie, Elizabeth O'Nions, Julia Bailey, Lorna Hobbs, Frank Gillespie, Irene Petersen","doi":"10.1136/bmjmed-2023-000499","DOIUrl":"10.1136/bmjmed-2023-000499","url":null,"abstract":"<p><strong>Objectives: </strong>To quantify the change in proportion of young people and adults identified as transgender in UK primary care records and to explore whether rates differ by age and socioeconomic deprivation.</p><p><strong>Design: </strong>Retrospective, dynamic, cohort study.</p><p><strong>Setting: </strong>IQVIA Medical Research Data, a database of electronic primary care records capturing data from 649 primary care practices in the UK between 1 January 2000 and 31 December 2018.</p><p><strong>Participants: </strong>7 064 829 individuals aged 10-99 years, in all four UK countries.</p><p><strong>Main outcome measures: </strong>Diagnostic codes indicative of transgender identity were used. Sex assigned at birth was estimated by use of masculinising or feminising medication and procedural/diagnostic codes.</p><p><strong>Results: </strong>2462 (0.03%) individuals had a record code indicating a transgender identity. Direction of transition could be estimated for 1340 (54%) people, of which 923 were assigned male at birth, and 417 were assigned female at birth. Rates of recording in age groups diverged substantially after 2010. Rates of the first recording of codes were highest in ages 16-17 years (between 2010 and 2018: 24.51/100 000 person years (95% confidence interval 20.95 to 28.50)). Transgender codes were associated with deprivation: the rate of the first recording was 1.59 (95% confidence interval 1.31 to 1.92) in the most deprived group in comparison with the least deprived group. Additionally, the rate ratio of the proportion of people who identified as transgender was 2.45 (95% confidence interval 2.28 to 2.65) in the most deprived group compared with the least deprived group. Substantial increases were noted in newly recorded transgender codes over time in all age groups (1.45/100 000 person years in 2000 (95% confidence interval 0.96 to 2.10) to 7.81/100 000 person years in 2018 (6.57 to 9.22)). In 2018, the proportion of people with transgender identity codes was highest in the age groups 16-17 years (16.23 per 10 000 (95% confidence interval 12.60 to 20.57)) and 18-29 years (12.42 per 10 000 (11.06 to 13.90)).</p><p><strong>Conclusion: </strong>The rate of transgender identity recorded in primary care records has increased fivefold from 2000 to 2018 and is highest in the 16-17 and 18-29 age groups. Transgender diagnostic coding is associated with socioeconomic deprivation and further work should investigate this association. Primary and specialist care should be commissioned accordingly to provide for the gender specific and general health needs of transgender people.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000499"},"PeriodicalIF":0.0,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
T cell immune memory after covid-19 and vaccination. covid-19和疫苗接种后的T细胞免疫记忆。
BMJ medicine Pub Date : 2023-11-22 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2022-000468
Lulu Wang, Alex Nicols, Lance Turtle, Alex Richter, Christopher Ja Duncan, Susanna J Dunachie, Paul Klenerman, Rebecca P Payne
{"title":"T cell immune memory after covid-19 and vaccination.","authors":"Lulu Wang, Alex Nicols, Lance Turtle, Alex Richter, Christopher Ja Duncan, Susanna J Dunachie, Paul Klenerman, Rebecca P Payne","doi":"10.1136/bmjmed-2022-000468","DOIUrl":"10.1136/bmjmed-2022-000468","url":null,"abstract":"<p><p>The T cell memory response is a crucial component of adaptive immunity responsible for limiting or preventing viral reinfection. T cell memory after infection with the SARS-CoV-2 virus or vaccination is broad, and spans multiple viral proteins and epitopes, about 20 in each individual. So far the T cell memory response is long lasting and provides a high level of cross reactivity and hence resistance to viral escape by variants of the SARS-CoV-2 virus, such as the omicron variant. All current vaccine regimens tested produce robust T cell memory responses, and heterologous regimens will probably enhance protective responses through increased breadth. T cell memory could have a major role in protecting against severe covid-19 disease through rapid viral clearance and early presentation of epitopes, and the presence of cross reactive T cells might enhance this protection. T cell memory is likely to provide ongoing protection against admission to hospital and death, and the development of a pan-coronovirus vaccine might future proof against new pandemic strains.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000468"},"PeriodicalIF":0.0,"publicationDate":"2023-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10668147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diet in the management of type 2 diabetes: umbrella review of systematic reviews with meta-analyses of randomised controlled trials 饮食在2型糖尿病管理中的作用:随机对照试验荟萃分析的系统综述
BMJ medicine Pub Date : 2023-11-01 DOI: 10.1136/bmjmed-2023-000664
Edyta Szczerba, Janett Barbaresko, Tim Schiemann, Anna Stahl-Pehe, Lukas Schwingshackl, Sabrina Schlesinger
{"title":"Diet in the management of type 2 diabetes: umbrella review of systematic reviews with meta-analyses of randomised controlled trials","authors":"Edyta Szczerba, Janett Barbaresko, Tim Schiemann, Anna Stahl-Pehe, Lukas Schwingshackl, Sabrina Schlesinger","doi":"10.1136/bmjmed-2023-000664","DOIUrl":"https://doi.org/10.1136/bmjmed-2023-000664","url":null,"abstract":"Objective To systematically summarise and evaluate the existing evidence on the effect of diet on the management of type 2 diabetes and prevention of complications. Design Umbrella review of systematic reviews with meta-analyses of randomised controlled trials. Data sources PubMed, Embase, Epistemonikos, and Cochrane, from inception up to 5 June 2022. Eligibility criteria for selecting studies Systematic reviews with meta-analyses of randomised controlled trials reporting summary effect estimates on the effect of diet on any health outcome in populations with type 2 diabetes were included in the review. Only meta-analyses with randomised controlled trials with the duration of at least 12 weeks were eligible for inclusion. Summary data were extracted by two investigators independently. Summary effect estimates with 95% confidence intervals were recalculated with a random effects model if the information provided was insufficient. Methodological quality was assessed with the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 tool and the certainty of evidence with the Grading of Recommendations Assessment, Development, and Evaluations (GRADE) approach. Results 88 publications with 312 meta-analyses of randomised controlled trials were included. Methodological quality was high to moderate in 23% and low to very low in 77% of the included publications. A high certainty of evidence was found for the beneficial effects of liquid meal replacement on reducing body weight (mean difference −2.37 kg, 95% confidence interval −3.30 to −1.44; n=9 randomised controlled trials included in the meta-analysis) and body mass index (−0.87, −1.32 to −0.43; n=8 randomised controlled trials), and of a low carbohydrate diet (<26% of total energy) on levels of haemoglobin A 1c (−0.47%, −0.60% to −0.34%; n=17 randomised controlled trials) and triglycerides (−0.30 mmol/L, −0.43 to −0.17; n=19 randomised controlled trials). A moderate certainty of evidence was found for the beneficial effects of liquid meal replacement, plant based, Mediterranean, high protein, low glycaemic index, and low carbohydrate diets (<26% total energy) on various cardiometabolic measures. The remaining results had low to very low certainty of evidence. Conclusions The evidence indicated that diet has a multifaceted role in the management of type 2 diabetes. An energy restricted diet can reduce body weight and improve cardiometabolic health. Beyond energy restriction, dietary approaches such as plant based, Mediterranean, low carbohydrate (<26% total energy), or high protein diets, and a higher intake of omega 3 fatty acids can be beneficial for cardiometabolic health in individuals with type 2 diabetes. Systematic review registration PROSPERO CRD42021252309.","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"17 5","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135565210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction:Effect of national guidance on survival for babies born at 22 weeks’ gestation in England and Wales: population based cohort study 更正:英格兰和威尔士国家指南对妊娠22周出生婴儿存活率的影响:基于人口的队列研究
BMJ medicine Pub Date : 2023-11-01 DOI: 10.1136/bmjmed-2023-000579corr1
{"title":"Correction:<i>Effect of national guidance on survival for babies born at 22 weeks’ gestation in England and Wales: population based cohort study</i>","authors":"","doi":"10.1136/bmjmed-2023-000579corr1","DOIUrl":"https://doi.org/10.1136/bmjmed-2023-000579corr1","url":null,"abstract":"[This corrects the article DOI: 10.1136/bmjmed-2023-000579.].","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"55 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135764839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial. 使用新冠肺炎恢复期血浆治疗因患有或不患有潜在免疫缺陷的新冠肺炎住院患者:开放标签随机临床试验。
BMJ medicine Pub Date : 2023-10-27 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2022-000427
Karine Lacombe, Thomas Hueso, Raphael Porcher, Arsene Mekinian, Thibault Chiarabini, Sophie Georgin-Lavialle, Florence Ader, Julien Saison, Guillaume Martin-Blondel, Nathalie De Castro, Fabrice Bonnet, Charles Cazanave, Anne Francois, Pascal Morel, Olivier Hermine, Valerie Pourcher, Marc Michel, Xavier Lescure, Nora Soussi, Phillipe Brun, Fanny Pommeret, Pierre Sellier, Stella Rousset, Lionel Piroth, Jean-Marie Michot, Gabriel Baron, Xavier de Lamballerie, Xavier Mariette, Pierre-Louis Tharaux, Matthieu Resche-Rigon, Philippe Ravaud, Tabassome Simon, Pierre Tiberghien
{"title":"Use of covid-19 convalescent plasma to treat patients admitted to hospital for covid-19 with or without underlying immunodeficiency: open label, randomised clinical trial.","authors":"Karine Lacombe,&nbsp;Thomas Hueso,&nbsp;Raphael Porcher,&nbsp;Arsene Mekinian,&nbsp;Thibault Chiarabini,&nbsp;Sophie Georgin-Lavialle,&nbsp;Florence Ader,&nbsp;Julien Saison,&nbsp;Guillaume Martin-Blondel,&nbsp;Nathalie De Castro,&nbsp;Fabrice Bonnet,&nbsp;Charles Cazanave,&nbsp;Anne Francois,&nbsp;Pascal Morel,&nbsp;Olivier Hermine,&nbsp;Valerie Pourcher,&nbsp;Marc Michel,&nbsp;Xavier Lescure,&nbsp;Nora Soussi,&nbsp;Phillipe Brun,&nbsp;Fanny Pommeret,&nbsp;Pierre Sellier,&nbsp;Stella Rousset,&nbsp;Lionel Piroth,&nbsp;Jean-Marie Michot,&nbsp;Gabriel Baron,&nbsp;Xavier de Lamballerie,&nbsp;Xavier Mariette,&nbsp;Pierre-Louis Tharaux,&nbsp;Matthieu Resche-Rigon,&nbsp;Philippe Ravaud,&nbsp;Tabassome Simon,&nbsp;Pierre Tiberghien","doi":"10.1136/bmjmed-2022-000427","DOIUrl":"10.1136/bmjmed-2022-000427","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy of covid-19 convalescent plasma to treat patients admitted to hospital for moderate covid-19 disease with or without underlying immunodeficiency (CORIPLASM trial).</p><p><strong>Design: </strong>Open label, randomised clinical trial.</p><p><strong>Setting: </strong>CORIMUNO-19 cohort (publicly supported platform of open label, randomised controlled trials of immune modulatory drugs in patients admitted to hospital with moderate or severe covid-19 disease) based on 19 university and general hospitals across France, from 16 April 2020 to 21 April 2021.</p><p><strong>Participants: </strong>120 adults (n=60 in the covid-19 convalescent plasma group, n=60 in the usual care group) admitted to hospital with a positive SARS-CoV2 test result, duration of symptoms <9 days, and World Health Organization score of 4 or 5. 49 patients (n=22, n=27) had underlying immunosuppression.</p><p><strong>Interventions: </strong>Open label randomisation to usual care or four units (200-220 mL/unit, 2 units/day over two consecutive days) of covid-19 convalescent plasma with a seroneutralisation titre >40.</p><p><strong>Main outcome measures: </strong>Primary outcomes were proportion of patients with a WHO Clinical Progression Scale score of ≥6 on the 10 point scale on day 4 (higher values indicate a worse outcome), and survival without assisted ventilation or additional immunomodulatory treatment by day 14. Secondary outcomes were changes in WHO Clinical Progression Scale scores, overall survival, time to discharge, and time to end of dependence on oxygen supply. Predefined subgroups analyses included immunosuppression status, duration of symptoms before randomisation, and use of steroids.</p><p><strong>Results: </strong>120 patients were recruited and assigned to covid-19 convalescent plasma (n=60) or usual care (n=60), including 22 (covid-19 convalescent plasma) and 27 (usual care) patients who were immunocompromised. 13 (22%) patients who received convalescent plasma had a WHO Clinical Progression Scale score of ≥6 at day 4 versus eight (13%) patients who received usual care (adjusted odds ratio 1.88, 95% credible interval 0.71 to 5.24). By day 14, 19 (31.6%) patients in the convalescent plasma group and 20 (33.3%) patients in the usual care group needed ventilation, additional immunomodulatory treatment, or had died. For cumulative incidence of death, three (5%) patients in the convalescent plasma group and eight (13%) in the usual care group died by day 14 (adjusted hazard ratio 0.40, 95% confidence interval 0.10 to 1.53), and seven (12%) patients in the convalescent plasma group and 12 (20%) in the usual care group by day 28 (adjusted hazard ratio 0.51, 0.20 to 1.32). In a subgroup analysis performed in patients who were immunocompromised, transfusion of covid-19 convalescent plasma was associated with mortality (hazard ratio 0.39, 95% confidence interval 0.14 to 1.10).</p><p><strong>Conclusions: </strong>In th","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000427"},"PeriodicalIF":0.0,"publicationDate":"2023-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10619082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71429673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Time to treat the climate and nature crisis as one indivisible global health emergency. 是时候将气候和自然危机视为一个不可分割的全球卫生紧急事件了。
BMJ medicine Pub Date : 2023-10-22 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000786
Chris Zielinski
{"title":"Time to treat the climate and nature crisis as one indivisible global health emergency.","authors":"Chris Zielinski","doi":"10.1136/bmjmed-2023-000786","DOIUrl":"https://doi.org/10.1136/bmjmed-2023-000786","url":null,"abstract":"","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000786"},"PeriodicalIF":0.0,"publicationDate":"2023-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10603515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71415671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Performance of polygenic risk scores in screening, prediction, and risk stratification: secondary analysis of data in the Polygenic Score Catalog. 多基因风险评分在筛查、预测和风险分层中的表现:多基因评分目录中数据的二次分析。
BMJ medicine Pub Date : 2023-10-17 eCollection Date: 2023-01-01 DOI: 10.1136/bmjmed-2023-000554
Aroon D Hingorani, Jasmine Gratton, Chris Finan, A Floriaan Schmidt, Riyaz Patel, Reecha Sofat, Valerie Kuan, Claudia Langenberg, Harry Hemingway, Joan K Morris, Nicholas J Wald
{"title":"Performance of polygenic risk scores in screening, prediction, and risk stratification: secondary analysis of data in the Polygenic Score Catalog.","authors":"Aroon D Hingorani, Jasmine Gratton, Chris Finan, A Floriaan Schmidt, Riyaz Patel, Reecha Sofat, Valerie Kuan, Claudia Langenberg, Harry Hemingway, Joan K Morris, Nicholas J Wald","doi":"10.1136/bmjmed-2023-000554","DOIUrl":"10.1136/bmjmed-2023-000554","url":null,"abstract":"<p><strong>Objective: </strong>To clarify the performance of polygenic risk scores in population screening, individual risk prediction, and population risk stratification.</p><p><strong>Design: </strong>Secondary analysis of data in the Polygenic Score Catalog.</p><p><strong>Setting: </strong>Polygenic Score Catalog, April 2022. Secondary analysis of 3915 performance metric estimates for 926 polygenic risk scores for 310 diseases to generate estimates of performance in population screening, individual risk, and population risk stratification.</p><p><strong>Participants: </strong>Individuals contributing to the published studies in the Polygenic Score Catalog.</p><p><strong>Main outcome measures: </strong>Detection rate for a 5% false positive rate (DR<sub>5</sub>) and the population odds of becoming affected given a positive result; individual odds of becoming affected for a person with a particular polygenic score; and odds of becoming affected for groups of individuals in different portions of a polygenic risk score distribution. Coronary artery disease and breast cancer were used as illustrative examples.</p><p><strong>Results: </strong>For performance in population screening, median DR<sub>5</sub> for all polygenic risk scores and all diseases studied was 11% (interquartile range 8-18%). Median DR<sub>5</sub> was 12% (9-19%) for polygenic risk scores for coronary artery disease and 10% (9-12%) for breast cancer. The population odds of becoming affected given a positive results were 1:8 for coronary artery disease and 1:21 for breast cancer, with background 10 year odds of 1:19 and 1:41, respectively, which are typical for these diseases at age 50. For individual risk prediction, the corresponding 10 year odds of becoming affected for individuals aged 50 with a polygenic risk score at the 2.5th, 25th, 75th, and 97.5th centiles were 1:54, 1:29, 1:15, and 1:8 for coronary artery disease and 1:91, 1:56, 1:34, and 1:21 for breast cancer. In terms of population risk stratification, at age 50, the risk of coronary artery disease was divided into five groups, with 10 year odds of 1:41 and 1:11 for the lowest and highest quintile groups, respectively. The 10 year odds was 1:7 for the upper 2.5% of the polygenic risk score distribution for coronary artery disease, a group that contributed 7% of cases. The corresponding estimates for breast cancer were 1:72 and 1:26 for the lowest and highest quintile groups, and 1:19 for the upper 2.5% of the distribution, which contributed 6% of cases.</p><p><strong>Conclusion: </strong>Polygenic risk scores performed poorly in population screening, individual risk prediction, and population risk stratification. Strong claims about the effect of polygenic risk scores on healthcare seem to be disproportionate to their performance.</p>","PeriodicalId":72433,"journal":{"name":"BMJ medicine","volume":"2 1","pages":"e000554"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582890/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49685693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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